17 Jan 2025
📜FDA's New Compliance Requirements for Adverse Event Reporting
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory text outlines compliance requirements for manufacturers, packers, distributors, and applicants of FDA-regulated drug products regarding postmarketing adverse experience reporting. This affects business operations, as companies must ensure adherence to electronic reporting protocols and maintain extensive records, impacting staffing and resource allocation.